The Early Detection Research Network Biomarker Reference Laboratories (U24) | Apply Online

Opportunity Summary:

The grant opportunity titled "The Early Detection Research Network Biomarker Reference Laboratories (U24)" (Funding Opportunity Number RFA-CA-14-016) is a National Institutes of Health (NIH) cooperative agreement designed to support a key component of the Early Detection Research Network (EDRN). EDRN is a national research infrastructure focused on improving early cancer detection by discovering, developing, and validating biomarkers that can be used for cancer risk assessment, early detection, and molecular diagnosis and prognosis. In practical terms, the program is meant to move promising biomarker ideas toward real-world clinical utility by building shared capacity, enforcing rigorous validation standards, and coordinating multi-site efforts so that biomarkers can be tested in a consistent, comparable way.

Within the EDRN structure, this specific FOA funds Biomarker Reference Laboratories (BRLs). BRLs are intended to function as specialized, high-quality laboratory hubs for the network. Their central responsibility is biomarker assay development and refinement specifically geared toward validation studies. That emphasis matters: BRLs are not just exploring new biomarker concepts, but are focused on making biomarker assays reliable, reproducible, and ready to be tested at scale across studies and sites. In addition to their own laboratory work, BRLs are expected to serve as a network-wide resource that supports both laboratory and clinical validation activities, meaning they help ensure that assays used in EDRN validation projects perform consistently and meet agreed-upon standards.

The FOA also makes clear how BRLs fit into the larger EDRN ecosystem, which is organized into four scientific units that work together. Biomarker Developmental Laboratories (BDLs) concentrate on discovering, developing, and characterizing new biomarkers, or improving existing biomarkers and assays, across the same use cases of risk assessment, detection, and molecular diagnosis and prognosis of early cancer. Clinical Validation Centers (CVCs) handle the clinical research side of validation, participating in collaborative validation studies with BDLs and BRLs and acting as resource centers for network projects that require patient-based testing and clinical study implementation. The Data Management and Coordinating Center (DMCC) provides the statistical and computational backbone of the network, including informatics infrastructure, study design support, coordination for EDRN-sponsored biomarker validation studies, and logistical coordination for network-wide meetings and conferences. The BRLs funded under this announcement are therefore positioned as the laboratory-standardization and assay-performance engine that enables credible downstream clinical validation.

From an administrative and funding standpoint, the award mechanism is a cooperative agreement (U24), meaning NIH is expected to have substantial programmatic involvement compared with a traditional grant. The opportunity is categorized under discretionary funding and falls under the health and education activity category, with CFDA number 93.394 (Cancer Detection and Diagnosis Research). The FOA estimated total funding is $2,000,000, with an award ceiling of $300,000 per award. Cost sharing or matching is not required, which lowers the barrier for applicants that may not have non-federal funds available to contribute.

Eligibility is broad and spans many types of domestic organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. Various government entities are eligible as well, including state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, and tribal governments (including federally recognized tribal governments) and other tribal organizations. The eligibility language also explicitly references several institution types and community-serving organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. However, the announcement draws a clear boundary around non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.

Key dates show this was a time-limited competition posted on November 6, 2014, created on December 12, 2014, with an original closing date of January 6, 2015, later extended to January 20, 2015. The opportunity was archived on February 19, 2015. The full announcement was hosted on the NIH grants website, and NIH provided contact support through the NIH Office of Extramural Research (OER) Webmaster for access or technical linking issues.

Overall, this FOA is best understood as NIH funding to build and operate high-functioning reference laboratory capability inside a national early-cancer biomarker network. The BRLs funded through this mechanism are meant to strengthen the quality and consistency of biomarker assays used in validation studies, act as shared resources for the wider EDRN community, and work in close coordination with biomarker discovery labs, clinical validation sites, and the network’s centralized data and coordinating center so that early detection biomarkers can be assessed rigorously and comparably across studies.

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